The present invention relates to an apparatus and method for imaging the anatomical structures of the uterus and fallopian tubes, and more particularly, to an apparatus and method for first injecting a sterile solution of saline into a uterus and its associated fallopian tubes to first observe the condition of the uterus and then generating air bubbles in the saline which are easily seen using an ultrasound scanner to sonographically observe the fallopian tubes.
Non-surgical diagnostic procedures for examining the uterus are well known. One such procedure known as hysterosonosalpingography, employs contrast agents and ultrasound imaging techniques for viewing the anatomical structures of the uterus and fallopian tubes. In hysterosonosalpingography, a fine flexible catheter equipped with an inflatable balloon is inserted into the cervical canal and/or into the uterus such that the balloon is positioned in the uterus or cervical canal. Once positioned, an inflation syringe associated with the catheter is used to inflate the balloon with saline to seal and block the cervical canal. A second injection syringe is then used to inject a contrast agent, such as Albunex manufactured by Mallinkrodt Medical, into the uterus, and subsequently into the fallopian tubes.
Albunex and other like contrast agents, are viscous solutions that include surface active agents which generate bubbles when shaken with air prior to injection into the uterus and fallopian tubes. These bubbles can be easily seen using an ultrasound scanner to sonographically observe the fallopian tubes.
Although conventional contrast agents function quite adequately, there are some disadvantages associated with them. One disadvantage is that they are very expensive and difficult for some gynecologists to obtain. Another disadvantage is that conventional contrast agents must be shaken prior to injection, thus making the entire diagnostic procedure cumbersome. A third disadvantage is a very short shelf life.
In response to the cost and unavailability of conventional contrast agents, other contrast mediums have been recently investigated. One such alternative contrast medium is air mixed with sterile solutions of saline. Recent studies indicate that air and saline can be used in place of conventional contrast agents in hysterosonosalpingography, as air and saline have the same contrasting capability as conventional contrast agents.
Unfortunately, conventional methods for generating air bubbles in saline are less than adequate and can be painful. Accordingly, an apparatus and method are needed for injecting a sterile solution of saline into a uterus to sonographically observe same and generating air bubbles in the saline which are easily seen using an ultrasound scanner to sonographically observe the fallopian tubes.
The invention is directed to an apparatus for sonographically observing a location of bodies, especially the uterus and fallopian tubes. The apparatus comprises a pump assembly and a catheter assembly fluidly coupled to the pump assembly. The pump assembly includes a first pump for pumping a solution of sterile saline into the catheter assembly and a second pump for pumping sterile air into the catheter assembly. The catheter assembly conveys the solution of sterile saline and the saline-air mixture into a location of a body.
The invention is further directed to a method for sonographically observing a location of a body, such as a uterus and its associated fallopian tubes, using the above apparatus. The method comprises the steps of inserting the catheter assembly into the location of the body, injecting the solution of sterile saline into the location of the body using the first pump of the pump assembly and the catheter assembly to observe its condition, injecting the micro-filtered air into the saline using the second pump of the pump assembly and the catheter assembly to generate air bubbles in the saline, injecting the saline with the air bubbles generated therein into the location of the body using the first and second pumps of the pump assembly and the catheter assembly, and ultrasonically imaging the location of the body to sonographically observe the location of the body using the bubbles generated in the saline.